DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method, a system for implementing the method and a computer programming to execute the method without significantly more. The claim(s) recite(s) “obtaining measured ultrasound data comprising an ultrasound image of the liver and corresponding radio frequency (RF) data of the liver; identifying a field of interest (FOI) in the ultrasound image; determining, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship; and enabling assessment of the fat in the liver based on the determined values”. This judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements, where the computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Each of Claims 1-20 recites at least one step or instruction for “obtaining measured ultrasound data comprising an ultrasound image of the liver and corresponding radio frequency (RF) data of the liver; identifying a field of interest (FOI) in the ultrasound image; determining, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship; and enabling assessment of the fat in the liver based on the determined values”, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claimed limitations humans performing observation, judgment or evaluation grouped as a mental process under the 2019 PEG. Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, Claim 1 recites
A method for quantitatively assessing fat of a liver, comprising: obtaining measured ultrasound data comprising an ultrasound image of the liver and corresponding radio frequency (RF) data of the liver; identifying a field of interest (FOI) in the ultrasound image; determining, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship; and enabling assessment of the fat in the liver based on the determined values.
Claim 11 recites:
11. A system for quantitatively assessing fat of a liver, comprising a point-of-care ultrasound (POCUS) device configured to obtain ultrasound data comprising an ultrasound image of the liver and corresponding radio frequency (RF) data of the liver; and one or more processors configured to receive the ultrasound data from the POCUS device and to: identify a field of interest (FOI) in the ultrasound image, determine, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship, generate a liver fat deposition map by assigning, to each of the graphical elements, a color associated with the values, and2enable display of the liver fat deposition map to allow assessment of the fat in the liver based on the determined values.
Claim 17 recites:
17. A computer program product having code stored thereon, the code, when executed by a processor, causing the processor to implement a method for quantitatively assessing fat of a liver, comprising: 3obtaining measured ultrasound data comprising an ultrasound image of the liver and corresponding radio frequency (RF) data of the liver; identifying a field of interest (FOI) in the ultrasound image, determining, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship; and enabling assessment of the fat in the liver based on the determined values.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-10, 12-16 and 18-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
The above-identified abstract idea in each of independent Claims 1, 11 and 17 (and their respective dependent Claims 2-10, 12-16 and 18-20) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1, 11 and 17), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of a processor, as recited in independent Claims 11 and 17 and its dependent claims; are generically recited computer elements in independent Claims 11 and 17 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 1, 11 and 17 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., a processor, as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 11 and 17 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1, 11, and 17 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
None of Claims 1-20 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: a processor, as recited in independent Claims 11 and 17 and its dependent claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93
Per Applicant’s specification, the processor, according to paragraphs 0052 and 0089, is generically described without structure or detailed drawings, e.g., schematic drawing or described as an iphone or ipad or mobile device or personal computer or laptop. Therefore, the processor is admittedly well understood, routine and conventional.
Accordingly, in light of Applicant’s specification, the claimed term processor, is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-20 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system and methods of Claims 1-20 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general-purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1-20 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 11 ad 17 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-20 amounts to significantly more than the abstract idea itself.
Accordingly, claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robert et al. (US 2023/0377246 A1).
With respect to claim 1, Robert discloses a method for quantitatively assessing fat of a liver, comprising: obtaining measured ultrasound data comprising an ultrasound image (see Abstract and paragraphs 0017-0018 for ultrasound image acquisition) of the liver and corresponding radio frequency (RF) data of the liver (see paragraphs 0003 and 0017-0018 discussing the fatty liver tissue in the imaging process); identifying a field of interest (FOI) in the ultrasound image (see paragraph 0022); determining, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship; and enabling assessment of the fat in the liver based on the determined values (see paragraph 0116-0118 discussing the relationship of the color pixel or voxels in the image of an area where the color pixel are considered as the claimed graphical element in the field of view).
With respect to claim 2, Robert discloses generating a liver fat deposition map showing deposition of the fat in the liver by assigning, to each of the graphical elements, a color associated with the values (see paragraph 0116-0118).
With respect to claims 3 and 12, Robert discloses the liver fat deposition map is two-dimensional or three-dimensional (see paragraph 0019), and each of the plurality of graphical elements is a pixel or voxel (see paragraph 0116-0118).
With respect to claim 4, Robert discloses superimposing the liver fat deposition map over the ultrasound image to enable visualization of one or more of the values at locations within the ultrasound image (see paragraphs 0016-0018 disclosing the overlaying process considered as the claimed superimposing step).
With respect to claims 5 and 20, Robert discloses ultrasound data is acquired using a point-of-care ultrasound (POCUS) device (see paragraph 0021 discussing a portable ultrasound system considered as the point of care ultrasound).
With respect to claims 6, 13 and 19, Robert discloses the pre-defined relationship is determined by: for each of a plurality of sample subjects, obtaining a measured ground truth data and sample ultrasound data of the sample subject, wherein the measured ground truth data of the sample subject comprises a distribution of liver fat metrics, wherein each of the liver fat metrics in the distribution is related to at least one of the one or more parameters; and determining the pre-defined relationship based on the measured ground truth data and the sample ultrasound data of the plurality of sample subjects (see paragraphs 0054-0058).
With respect to claims 7 and 14, Robert discloses the measured ground truth data comprises magnetic resonance imaging (MRI) (see paragraph 0062).
With respect to claims 8 and 15, Robert discloses one or more parameters of interest comprise one or more of an attenuation coefficient (see paragraphs 0003 and 0046), a backscatter coefficient (see paragraph 0050), a Lizzi-Feleppa slope, a Lizzi- Feleppa intercept, a Kappa, or a Mu.
With respect to claims 9 and 16, Robert discloses determining a value of the fat in the liver for each of the graphical elements based on the values of the one or more parameters of interest of the graphical element or a combination of the values of the one or more parameters of interest of the graphical element (see paragraph 0051 discussing stiffness and attenuation parameters of the tissue used when assigning different colors to the tissue to differentiate the values).
With respect to claim 10, Robert discloses the method is implemented to provide a diagnosis of the liver or a grading of fat in the liver (see paragraph 0051-0052).
With respect to claim 11, Robert discloses a system for quantitatively assessing fat of a liver, comprising a point-of-care ultrasound (POCUS) device configured to obtain ultrasound data (see paragraph 0021 discussing a portable ultrasound system considered as the point of care ultrasound; See Figure 2 showing the ultrasound device having probe #212) comprising an ultrasound image of the liver and corresponding radio frequency (RF) data of the liver (see paragraphs 0003 and 0017-0018 discussing the fatty liver tissue in the ultrasound imaging process); and one or more processors configured to receive the ultrasound data from the POCUS
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device and to (see processor #226 to process the received signals): identify a field of interest (FOI) in the ultrasound image (see paragraph 0022), determine, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship, generate a liver fat deposition map by assigning, to each of the graphical elements, a color associated with the values, and enable display of the liver fat deposition map to allow assessment of the fat in the liver based on the determined values (see paragraph 0116-0118 discussing the relationship of the color pixel or voxels in the image of an area where the color pixel are considered as the claimed graphical element in the field of view to depict the generation of a liver fat map; see Figure 2 showing the processor #268 for image generation to be display on display #238).
With respect to claim 17, Robert discloses a computer program product having code stored thereon, the code, when executed by a processor, causing the processor to implement a method for quantitatively assessing fat of a liver, comprising: obtaining measured ultrasound data comprising an ultrasound image (see Abstract and paragraphs 0017-0018 for ultrasound image acquisition) of the liver and corresponding radio frequency (RF) data of the liver (see paragraphs 0003 and 0017-0018 discussing the fatty liver tissue in the imaging process); identifying a field of interest (FOI) in the ultrasound image (see paragraph 0022), determining, for each of a plurality of graphical elements that are within the FOI, values of one or more parameters of interest that are indirect measures of the fat in the liver using the RF data and a pre-defined relationship; and enabling assessment of the fat in the liver based on the determined values (see paragraph 0116-0118 discussing the relationship of the color pixel or voxels in the image of an area where the color pixel are considered as the claimed graphical element in the field of view to depict the generation of a liver fat map).
With respect to claim 18, Robert discloses the method further comprises generating a liver fat deposition map showing deposition of the fat in the liver by assigning, to each of the graphical elements, a color associated with the values (see paragraph 0116-0118), wherein the liver fat deposition map is two-dimensional or three-dimensional (see paragraph 0019), and each of the plurality of graphical elements is a pixel or voxel (see paragraph 0116-0118).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses ultrasound devices to image fatty liver and assign coloring to different aspects of the image to create contrast between the parameters.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798